StaphVAX in Cardiovascular Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211913
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007

September 13, 2005
December 26, 2007
June 2004
October 2005   (final data collection date for primary outcome measure)
Serotype-specific antibody concentrations [ Time Frame: 6 weeks after the vaccine dose ] [ Designated as safety issue: No ]
Serotype-specific antibody concentrations six weeks after the vaccine dose.
Complete list of historical versions of study NCT00211913 on ClinicalTrials.gov Archive Site
  • Serotype-specific antibody concentrations [ Time Frame: at other time points 7-180 days after the vaccine dose. ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 0-180 days after vaccine dose ] [ Designated as safety issue: Yes ]
  • Serotype-specific antibody concentrations at other time points after the vaccine dose.
  • Safety.
Not Provided
Not Provided
 
StaphVAX in Cardiovascular Surgery Patients
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Undergoing Cardiovascular Surgery

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Staphylococcal Infections
  • Cardiovascular Diseases
  • Cardiovascular Surgical Procedures
  • Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
    single IM dose totalling 200 mcg of conjugate
    Other Name: StaphVAX®
  • Biological: placebo
    single IM dose
  • Experimental: vaccine
    single dose of StaphVAX®
    Intervention: Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
  • Placebo Comparator: placebo
    single dose
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2006
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidate for cardiovascular surgery
  • Expected to comply with protocol
  • Negative pregnancy test where appropriate
  • Written informed consent

Exclusion Criteria:

  • Known S. aureus infection in past 3 months
  • Known infection in the past 2 weeks
  • Known HIV infection
  • Pregnancy or breast-feeding
  • Immunomodulatory drugs
  • Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
  • investigational drugs, vaccines or products in the past 30 days
  • Hypersensitivity to components of StaphVAX
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211913
Nabi-1366
No
Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nai Biopharmaceuticals
Nabi Biopharmaceuticals
Not Provided
Study Director: Preston Holley, MD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP